Study of Efficacy and Safety of Percutaneous Coronary Intervention to Improve Survival in Heart Failure

NCT ID: NCT01920048

Last Updated: 2022-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

700 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-28

Study Completion Date

2022-03-31

Brief Summary

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This study will assess whether percutaneous coronary intervention (angioplasty of the heart arteries) can improve survival and reduce hospitalization in patients with heart failure due to coronary disease, who have been treated with the best contemporary medical therapy.

Detailed Description

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Conditions

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Ischemic Cardiomyopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Percutaneous Coronary Intervention and Optimal Medical Therapy

Group Type EXPERIMENTAL

Percutaneous Coronary Intervention

Intervention Type PROCEDURE

Drug Therapy for Heart Failure

Intervention Type DRUG

The optimal combination of drugs and doses for each patient will be individualized and will be determined by his/her physician, in accordance with local and international clinical practice guidelines

Device Therapy for Heart Failure

Intervention Type DEVICE

The optimal device therapy for each patient will be individualized and will be determined by his/her physician, in accordance with local and international clinical practice guidelines. In most cases the device will be an Implantable Cardioverter Defibrillator and/or Cardiac Resynchronization Therapy.

Optimal Medical Therapy alone

Group Type ACTIVE_COMPARATOR

Drug Therapy for Heart Failure

Intervention Type DRUG

The optimal combination of drugs and doses for each patient will be individualized and will be determined by his/her physician, in accordance with local and international clinical practice guidelines

Device Therapy for Heart Failure

Intervention Type DEVICE

The optimal device therapy for each patient will be individualized and will be determined by his/her physician, in accordance with local and international clinical practice guidelines. In most cases the device will be an Implantable Cardioverter Defibrillator and/or Cardiac Resynchronization Therapy.

Interventions

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Percutaneous Coronary Intervention

Intervention Type PROCEDURE

Drug Therapy for Heart Failure

The optimal combination of drugs and doses for each patient will be individualized and will be determined by his/her physician, in accordance with local and international clinical practice guidelines

Intervention Type DRUG

Device Therapy for Heart Failure

The optimal device therapy for each patient will be individualized and will be determined by his/her physician, in accordance with local and international clinical practice guidelines. In most cases the device will be an Implantable Cardioverter Defibrillator and/or Cardiac Resynchronization Therapy.

Intervention Type DEVICE

Other Intervention Names

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Coronary angioplasty/stents

Eligibility Criteria

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Inclusion Criteria

ALL of the following:

1. Poor left ventricular function (EF≤35%)
2. Extensive coronary disease
3. Viability in at least 4 dysfunctional segments that can be revascularised by PCI

Exclusion Criteria

1. Myocardial infarction \< 4 weeks prior to randomisation (clinical definition)
2. Decompensated heart failure requiring inotropic support, invasive or non-invasive ventilation or Intra-aortic Balloon Pump/left ventricular assist device therapy \<72 hours prior to randomization
3. Sustained Ventricular Tachycardia/Ventricular Fibrillation or appropriate Implantable Cardioverter Defibrillator discharges \<72 hours prior to randomization
4. Valve disease requiring intervention
5. Contraindications to percutaneous coronary intervention
6. Age \<18 yrs
7. Estimated Glomerular Filtration Rate \< 25 ml/min, unless established on dialysis
8. Women who are pregnant
9. Previously enrolled in REVIVED-BCIS2 or current enrollment in other study that may affect REVIVED-BCIS2 outcome data
10. Life expectancy \< 1 yr due to non-cardiac pathology
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Health Research, United Kingdom

OTHER_GOV

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role collaborator

University of York

OTHER

Sponsor Role collaborator

Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role lead

Responsible Party

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Divaka Perera

Consultant Cardiologist and Professor of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Divaka Perera, MB BChir, MA, MD, FRCP

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

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Basingstoke and North Hampshire Hospital

Basingstoke, , United Kingdom

Site Status

Royal Victoria Hospital

Belfast, , United Kingdom

Site Status

Birmingham Heartlands Hospital

Birmingham, , United Kingdom

Site Status

Blackpool Victoria Hospital

Blackpool, , United Kingdom

Site Status

North Wales Cardiac Centre

Bodelwyddan, , United Kingdom

Site Status

Royal Bournemouth Hospital

Bournemouth, , United Kingdom

Site Status

Bristol Heart Institute

Bristol, , United Kingdom

Site Status

University Hospital Coventry

Coventry, , United Kingdom

Site Status

Dorset County Hospital

Dorchester, , United Kingdom

Site Status

Ninewells Hospital

Dundee, , United Kingdom

Site Status

Royal Infirmary of Edinburgh

Edinburgh, , United Kingdom

Site Status

Royal Devon and Exeter Hospital

Exeter, , United Kingdom

Site Status

Golden Jubilee National Hospital

Glasgow, , United Kingdom

Site Status

Kettering General Hospital

Kettering, , United Kingdom

Site Status

Leeds General Infirmary

Leeds, , United Kingdom

Site Status

Glenfield Hospital

Leicester, , United Kingdom

Site Status

Liverpool Heart and Chest Hospital

Liverpool, , United Kingdom

Site Status

Barts Heart Centre

London, , United Kingdom

Site Status

Royal Free Hospital

London, , United Kingdom

Site Status

Guy's and St Thomas' Hospital

London, , United Kingdom

Site Status

King's College Hospital

London, , United Kingdom

Site Status

St George's Hospital

London, , United Kingdom

Site Status

Manchester Royal Infirmary

Manchester, , United Kingdom

Site Status

The James Cook University Hospital

Middlesbrough, , United Kingdom

Site Status

Freeman Hospital

Newcastle, , United Kingdom

Site Status

Royal Oldham Hospital

Oldham, , United Kingdom

Site Status

Derriford Hospital

Plymouth, , United Kingdom

Site Status

Queen Alexandra Hospital

Portsmouth, , United Kingdom

Site Status

Salisbury District Hospital

Salisbury, , United Kingdom

Site Status

Northern General Hospital

Sheffield, , United Kingdom

Site Status

Southampton General Hospital

Southampton, , United Kingdom

Site Status

Lister Hospital

Stevenage, , United Kingdom

Site Status

Sunderland Royal Hospital

Sunderland, , United Kingdom

Site Status

Great Western Hospital

Swindon, , United Kingdom

Site Status

Pinderfields Hospital

Wakefield, , United Kingdom

Site Status

New Cross Hospital

Wolverhampton, , United Kingdom

Site Status

Worcestershire Royal Hospital

Worcester, , United Kingdom

Site Status

Worthing Hospital

Worthing, , United Kingdom

Site Status

Wythenshawe Hospital

Wythenshawe, , United Kingdom

Site Status

York Hospital

York, , United Kingdom

Site Status

Countries

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United Kingdom

References

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Ovesen C, Dodd M, Ryan M, Clayton T, Sharples L, Perera D. Impact of baseline risk of death or hospitalisation on effectiveness of revascularisation in patients with ischaemic left ventricular dysfunction - a prespecified analysis of REVIVED-BCIS2. Eur Heart J Qual Care Clin Outcomes. 2025 Sep 16:qcaf108. doi: 10.1093/ehjqcco/qcaf108. Online ahead of print.

Reference Type DERIVED
PMID: 40972554 (View on PubMed)

Ezad SM, McEntegart M, Dodd M, Didagelos M, Sidik N, Li Kam Wa M, Morgan HP, Pavlidis A, Weerackody R, Walsh SJ, Spratt JC, Strange J, Ludman P, Chiribiri A, Clayton T, Petrie MC, O'Kane P, Perera D; REVIVED-BCIS2 Investigators. Impact of Anatomical and Viability-Guided Completeness of Revascularization on Clinical Outcomes in Ischemic Cardiomyopathy. J Am Coll Cardiol. 2024 Jul 23;84(4):340-350. doi: 10.1016/j.jacc.2024.04.043. Epub 2024 May 15.

Reference Type DERIVED
PMID: 38759904 (View on PubMed)

Ryan M, Taylor D, Dodd M, Spertus JA, Kosiborod MN, Shaukat A, Docherty KF, Clayton T, Perera D, Petrie MC; REVIVED-BCIS2 Investigators. Effect of PCI on Health Status in Ischemic Left Ventricular Dysfunction: Insights From REVIVED-BCIS2. JACC Heart Fail. 2024 Sep;12(9):1553-1562. doi: 10.1016/j.jchf.2024.03.010. Epub 2024 Apr 8.

Reference Type DERIVED
PMID: 38727649 (View on PubMed)

Chivardi C, Morgan H, Sculpher MJ, Clayton T, Evans R, Dodd M, Petrie M, Rinaldi CA, O'Kane P, Brown L, Perera D, Saramago P; REVIVED-BCIS2 Investigators. Percutaneous Revascularization for Ischemic Left Ventricular Dysfunction: Cost-Effectiveness Analysis of the REVIVED-BCIS2 Trial. Circ Cardiovasc Qual Outcomes. 2024 Jan;17(1):e010533. doi: 10.1161/CIRCOUTCOMES.123.010533. Epub 2023 Nov 6.

Reference Type DERIVED
PMID: 37929587 (View on PubMed)

Perera D, Ryan M, Morgan HP, Greenwood JP, Petrie MC, Dodd M, Weerackody R, O'Kane PD, Masci PG, Nazir MS, Papachristidis A, Chahal N, Khattar R, Ezad SM, Kapetanakis S, Dixon LJ, De Silva K, McDiarmid AK, Marber MS, McDonagh T, McCann GP, Clayton TC, Senior R, Chiribiri A; REVIVED-BCIS2 Investigators. Viability and Outcomes With Revascularization or Medical Therapy in Ischemic Ventricular Dysfunction: A Prespecified Secondary Analysis of the REVIVED-BCIS2 Trial. JAMA Cardiol. 2023 Dec 1;8(12):1154-1161. doi: 10.1001/jamacardio.2023.3803.

Reference Type DERIVED
PMID: 37878295 (View on PubMed)

Perera D, Morgan HP, Ryan M, Dodd M, Clayton T, O'Kane PD, Greenwood JP, Walsh SJ, Weerackody R, McDiarmid A, Amin-Youssef G, Strange J, Modi B, Lockie T, Hogrefe K, Ahmed FZ, Behan M, Jenkins N, Abdelaal E, Anderson M, Watkins S, Evans R, Rinaldi CA, Petrie MC; REVIVED-BCIS2 Investigators. Arrhythmia and Death Following Percutaneous Revascularization in Ischemic Left Ventricular Dysfunction: Prespecified Analyses From the REVIVED-BCIS2 Trial. Circulation. 2023 Sep 12;148(11):862-871. doi: 10.1161/CIRCULATIONAHA.123.065300. Epub 2023 Aug 9.

Reference Type DERIVED
PMID: 37555345 (View on PubMed)

Ezad SM, Ryan M, Perera D. Can Percutaneous Coronary Intervention Revive a Failing Heart? Heart Int. 2022 Dec 21;16(2):72-74. doi: 10.17925/HI.2022.16.2.72. eCollection 2022.

Reference Type DERIVED
PMID: 36741102 (View on PubMed)

Perera D, Clayton T, O'Kane PD, Greenwood JP, Weerackody R, Ryan M, Morgan HP, Dodd M, Evans R, Canter R, Arnold S, Dixon LJ, Edwards RJ, De Silva K, Spratt JC, Conway D, Cotton J, McEntegart M, Chiribiri A, Saramago P, Gershlick A, Shah AM, Clark AL, Petrie MC; REVIVED-BCIS2 Investigators. Percutaneous Revascularization for Ischemic Left Ventricular Dysfunction. N Engl J Med. 2022 Oct 13;387(15):1351-1360. doi: 10.1056/NEJMoa2206606. Epub 2022 Aug 27.

Reference Type DERIVED
PMID: 36027563 (View on PubMed)

Perera D, Clayton T, Petrie MC, Greenwood JP, O'Kane PD, Evans R, Sculpher M, Mcdonagh T, Gershlick A, de Belder M, Redwood S, Carr-White G, Marber M; REVIVED investigators. Percutaneous Revascularization for Ischemic Ventricular Dysfunction: Rationale and Design of the REVIVED-BCIS2 Trial: Percutaneous Coronary Intervention for Ischemic Cardiomyopathy. JACC Heart Fail. 2018 Jun;6(6):517-526. doi: 10.1016/j.jchf.2018.01.024.

Reference Type DERIVED
PMID: 29852933 (View on PubMed)

Other Identifiers

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ISRCTN45979711

Identifier Type: OTHER

Identifier Source: secondary_id

ISRCTN45979711

Identifier Type: -

Identifier Source: org_study_id

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